510(k) Report

510(k) · Cleared

Cleared

Color LCD Monitor, Model Radiforce MX241W

K092741510(k) SpecialCleared Nov 10, 200963-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Eizo Nanao Corporation · LLZ System, Image Processing, Radiological

Cleared on Nov 10, 2009 as substantially equivalent to K073340 (Eizo Nanao Corporation, 2007) after a 63-day review. Its family tree reaches back 3 generations to 2004.

Decided
Nov 10, 2009
Review
63 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K033466 (2004). No later device cites it as a predicate yet.

  1. Root · 3 generations backK033466 Color LCD Display, Model Radiforce R22Eizo Nanao Corporation · 2004
  2. 2 generations backK052344 Color LCD Monitor, Model Radioforce R31 & R31-CEizo Nanao Corporation · 2005
  3. 1 generation backK073340 Color LCD Monitor, Flexscan MX300WEizo Nanao Corporation · 2007
  4. This deviceK092741 Color LCD Monitor, Model Radiforce MX241WEizo Nanao Corporation · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K033466Color LCD Display, Model Radiforce R22Eizo Nanao Corporation2004—
−2K052344Color LCD Monitor, Model Radioforce R31 & R31-CEizo Nanao Corporation2005—
−1K073340Color LCD Monitor, Flexscan MX300WEizo Nanao Corporation2007—
0 (this device)K092741Color LCD Monitor, Model Radiforce MX241WEizo Nanao Corporation2009—
FIG. 1 — Lineage of K092741, 2004–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LLZ device

  1. #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K073340Color LCD Monitor, Flexscan MX300W
Summary page 1
…Predicate Device Manufacturer EIZO NANAO CORPORATION Device Name Color LCD Monitor Model Name FlexScan MX300W 510(k) No. K073340 5. Description of Device RadiForce MX241W is 61cm Color LCD display for medical image viewing digital images viewing. 9…
Eizo Nanao Corporation2007—

Also cleared against K073340: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 1.9 years on median.
  • None of the 3 ancestors has a recall.
  • 3 other devices also cite its predicate K073340.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

What is it indicated for?

RadiForce MX241W is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce MX241W does not support the display of mammography images for diagnosis.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K092741: Color LCD Monitor, Model Radiforce MX241W.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092741

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026